Z-2092-2012 Class II Terminated
FDA device recall Z-2092-2012 was initiated by Zimmer Inc. on Apr 30, 2012 and is designated Class II. Reason for recall: The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design… The recall status is terminated (terminated Jun 4, 2014). Affected quantity: 65 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2012
- Initiation Date
- Apr 30, 2012
- Termination Date
- Jun 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 units
Product Description
Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Reason for Recall
The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland.
Code Information
Part 00-5901-026-40 Lot 62011774, 61870067, and 61813699 Initially the 00-5901-026-40 replacement jaws will remain available for order until all of the alternative instruments are in place, however they will also be required to be returned. The final lot numbers and manufacture dates will be provided in a subsequent status update.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2092-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026